Precision Align LLC
Form 483 issued July 20, 2023 · Fort Lauderdale, Florida
- Inspection
- Jul 17 – Jul 20, 2023
- Investigator
- Ebony D. Sanon
- Observations
- 6
- Pages
- 4
- FEI number
- 3021554422
In short: On July 20, 2023, FDA issued a Form 483 with 6 observations to Precision Align LLC in Fort Lauderdale, Florida (FEI 3021554422) after an inspection that ran Jul 17 – Jul 20, 2023. The investigator was Ebony D. Sanon. Most observations concern production & process controls and records & documents.
At a glance
Production & process controls and records & documents account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for device history records have…
- 02
Written MDR procedures have…
- 03
Requirements that must be met by suppliers and consultants…
- 04
Procediues for acceptance of incoming product have…
This inspection in context
Ebony D. Sanon
8 documents · 2022–2026
Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in Florida.
The firmPrecision Align LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Precision Align LLC?
FDA listed 6 observations on this Form 483, mostly about production & process controls, records & documents and cAPA. The opening words of each observation are shown on this page.
Who inspected Precision Align LLC?
Ebony D. Sanon is named on this Form 483, for the inspection of Jul 17 – Jul 20, 2023. Each investigator has a profile showing what they cite most.
When was Precision Align LLC inspected by FDA?
The inspection ran Jul 17 – Jul 20, 2023, and the Form 483 is dated July 20, 2023.
How do I get the full Form 483 for Precision Align LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.